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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K150271
FOIA Releasable 510(k) K150271
Device Name Prime Adaptive Ultrasonic Scalpel System
Applicant
Endoprime, Inc.
4480 Lake Forest Dr., Suite 412
Blue Ash,  OH  45242
Applicant Contact RICHARD GRANT
Correspondent
Endoprime, Inc.
4480 Lake Forest Dr., Suite 412
Blue Ash,  OH  45242
Correspondent Contact RICHARD GRANT
Classification Product Code
LFL  
Date Received02/04/2015
Decision Date 05/29/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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